EXMOOR

Primary DI
05060180258788
Brand
EXMOOR
Company
EXMOOR PLASTICS LIMITED
Model
EPL/1a
Catalog number
EPL1A
Device description
Epidrum
Published
2018-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093863000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093863000EPIDRUMExmoor Plastics , Ltd.2010-05-10FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060180252113PackageGS1100Not in Commercial Distribution
05060180258788PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060180252113050601802521135060180252113
05060180258788050601802587885060180258788

GMDN Terms#

Term, Definition table
TermDefinition
Manual epidural space locatorA sterile device intended to be used in conjunction with an epidural needle to aid a user in locating the epidural needle tip within the epidural space. It is typically a small chamber made of synthetic polymers with Luer inlet and exit ports on opposing sides and an expandable membrane (diaphragm) as one of the sides between the ports. The device is inserted between the syringe and epidural needle and its diaphragm is inflated with air; the needle is inserted into the patient until the diaphragm collapses signalling entry into the epidural space. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a clean, dry environment, at room temperature. Avoid extremes of temperature and humidity.
Special Storage Condition, Specify00Store out of direct sunlight.
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius35 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+441823351040sales@exmoorltd.com

Regulatory Flags#

DUNS number
298725490
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060180256043EXMOORE.111E111 or E111X52018-09-10
05060180256180EXMOORE402E4022018-09-11
05060180256272EXMOORE.59E592018-09-20
05060180256319EXMOORL1L12018-09-10
05060180257798EXMOORS101S101-EX2018-09-11
05060180257866EXMOORS102S102-EX2018-09-11
05060180257873EXMOORS103S103-EX2018-09-11
05060180257880EXMOORS104S104-EX2018-09-11
05060180257934EXMOORS109S109-EX2018-09-11
05060180257972EXMOORS110S110-EX2018-09-11
05060180257989EXMOORS111S111-EX2018-09-11
05060180258139EXMOORS125S125-EX2018-09-11
05060180256258EXMOORE.58E582018-09-20
05060180256265EXMOORE.58aE58A2018-09-20
05060180256159EXMOORE.301E3012018-09-10
05060180251048EXMOORN18N182018-09-14
05060180251062EXMOORN23N232018-09-17
05060180251642EXMOORMK/82/A/E107MK82AE1072018-10-09
05060180251659EXMOORMK/82/A/E108MK82AE1082018-10-09
05060180252083EXMOORE.302E.3022018-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391530753968FD-1019NS - 1ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754088FD-1021NS 3ml PC Syringe White PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754194FD-1034NS 20ml PC Syringe Red PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754224FD-1033NS 20ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754231FD-1092NS 20ml PC Syringe Heparin Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530753456FD-1032NS - 20ml PC Syringe Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753463FD-1031NS - 20ml PC Syringe White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753487FD-1113NS - 10ml PC Syringe Contrast Dark Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753517FD-1051NS - 10ml PC Syringe Purple Plunger - Lidocaine PrintDMC MEDICAL LIMITEDFMF2026-06-01
05391530753524FD-1043NS - 10ml PC Syringe - Contrast - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753531FD-1107NS - 30ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753548FD-1026NS - 10ml PC Syringe - White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753555FD-1158NS - 10ml PC Syringe - Heparin/Saline White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753562FD-1049NS - 10ml PC Syringe - Lidocaine Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753579FD-1029NS - 10ml PC Syringe Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753593FD-1054NS - 10ml PC Syringe - Nitro Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753609FD-1039NS - 10ml PC Syringe - Heparin Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753616FD-1071NS - 10ml PC Syringe - Purple PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753623FD-1028NS - 10ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753647FD-1072NS - 10ml PC Syringe Dark Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753654FD-1030NS - 10ml PC Syringe - Light Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753661FD-1042NS - 10ml PC Syringe - Contrast Print - Light Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753678FD-1044NS - 10ml PC Syringe - Contrast Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753685FD-1045NS - 10ml PC Syringe - Contrast Print - White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753692FD-1046NS - 10ml PC Syringe Contrast Light Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753708FD-1047NS - 10ml PC Syringe - Lidocaine Print - Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753715FD-1103NS - 20ml PC Syringe - Purple PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753722FD-1027NS - 10ml PC Syringe Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753753FD-1067NS - 3ml PC Syringe - Nitro Print - Purple PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753760FD-1038NS - 10ml PC Syringe Heparin Print Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01